FDA advisory panel holds HGS's future in its hands

Shares of Human Genome Sciences ($HGSI) gradually climbed back up the charts yesterday as investors got a chance to soak in one last round of upbeat analyst remarks ahead of today's crucial FDA advisory panel meeting on Benlysta, an experimental therapy angling to become the first new drug for lupus in half a century.

It would be hard to overstate the importance of today's vote for Human Genome Sciences. The biotech company is bidding for its first approval, and an OK from the FDA would lay the foundation for blockbuster revenue that can be split between HGS and GlaxoSmithKline ($GSK). Thomson Reuters has estimated potential peak revenue at more than $2 billion a year.

The reason for the bump in share price Monday was that most analysts still give Benlysta a solid shot at an approval, despite lackluster efficacy data and serious safety issues regarding infections, increased risk of death and suicide. But J .P. Morgan analyst Cory Kasimov is telling investors that regulators are likely to overlook even serious risks when given the chance to approve a new drug for lupus--a serious unmet medical need by any standard. And he adds that the FDA has five years of safety data to look at--enough to likely forgo the need for additional studies ahead of an approval.

Dr. Michelle Petri, a rheumatologist at Johns Hopkins University and consultant to Human Genome, was on hand today to help lead the charge for HGS, noting that lupus patients have "persevered through a decade of failed trials." Of course there have been plenty of surprises during this year's panel votes, and we'll be posting the results on the website as soon as it's available.

- here's the story from Reuters

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